BRUSSELS: European regulators on Friday recommended approving with conditions Johnson & Johnson’s (J&J) blood cancer drug, saying they would need to evaluate additional data from two ongoing studies.
Darzalex (daratumumab), which has already been approved in the US, offers hope to patients who have run out of options to fight multiple myeloma.
The European Medicines Agency’s (EMA) recommendation applies to the use of the antibody treatment in adults who have already undergone standard treatments for multiple myeloma.
The EMA grants conditional approval for drugs that fill an unmet medical need for serious conditions and show early evidence of clinical benefits outweighing the risks.
Multiple myeloma is a form of cancer that affects infection-fighting plasma cells in the bone marrow. It can lead to complications such as infections, fractures and kidney dysfunction.
In 2012, about 39,000 people suffered from multiple myeloma in the EU, according to the EMA.
Only half of the patients diagnosed with the condition are alive after five years as they develop resistance to existing therapies.
The current therapies include Takeda Pharmaceutical Co Ltd’s Velcade, Celgene Corp’s Revlimid, and newer drugs such as Amgen Inc’s Kyprolis and Celgene’s Pomalyst.
Darzalex, given as an infusion, works by helping the immune system attack cancer cells.
Researchers say it is the first antibody shown to be effective against myeloma without being combined with other medicines.
Janssen, a unit of Johnson & Johnson, licensed daratumumab from Danish biotech company Genmab under an exclusive deal in 2012.
Genmab said separately that it expected a final decision from the European Commission in 60 to 90 days.
Analysts, on average, believe Darzalex could generate annual sales of US$2.19 billion by 2020, according to Thomson Reuters Cortellis data.
The drug won early approval from the US Food and Drug Administration in November last year for patients who had already undergone at least three prior standard treatments.
The EMA has asked for additional results from the two ongoing, late-stage studies testing the antibody in combination with standard treatments.
Data from both studies are to be released by the second half of next year, the regulator said, adding it would weigh Darzalex’s benefits and risks every year until then.
